- Approval Id
- 7ce2cdec6e49efa9
- Drug Name
- XENETIX 300 INJECTION 300 MGI/ML
- Product Name
- XENETIX 300 INJECTION 300 MGI/ML
- Approval Number
- SIN08866P
- Approval Date
- 1996-08-22
- Registrant
- TRANSMEDIC PTE LTD
- Licence Holder
- TRANSMEDIC PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION
- Dosage
- <p><strong>4.2. Posology and method of administration</strong></p>
<p>The doses must be adapted to the examination and the regions to be opacified, as well as to the body weight and renal function of the subject.<br>
There is no data about the use of Xenetix in pediatric patients. Therefore, the use of Xenetix is not recommended in pediatric patients.<br>
Usually the same iodine concentration and volume are used as with other iodinated X-ray contrast in current use. As with all contrast media, the lowest dose necessary to obtain adequate visualisation should be used.<br>
Adequate hydration should be assured before and after administration as for other contrast media. Usually, the rate of administration varies between 0.5 and 5 ml/s depending on the type of examination.</p>
<p><strong>Xenetix® 300</strong><br>
<strong>Recommended mean dosages for intravascular routes:</strong></p>
<img src="/TGIF/Xenetix-Table2.png" alt="Xenetix Dosage Table 2" /><br><br>
<p><strong>Xenetix® 300</strong><br>
<strong>Recommended mean dosages for intracavitary routes:</strong></p>
<img src="/TGIF/Xenetix-Table3.png" alt="Xenetix Dosage Table 3" /><br><br>
<p><strong>Xenetix® 350</strong><br>
<strong>Recommended mean dosages for intravascular routes:</strong></p>
<img src="/TGIF/Xenetix-Table4.png" alt="Xenetix Dosage Table 4" /><br><br>
- Route Of Administration
- INTRAVASCULAR
- Indication Info
- <p><strong>4.1. Therapeutic indications</strong></p>
<p>This medicinal product is for diagnostic use only.<br>
Contrast agent for use in:</p>
<img src="/TGIF/Xenetix-Table1.png" alt="Xenetix Indications Table 1" /><br><br>
- Contraindications
- <p><strong>4.3. Contraindication</strong></p>
<ul>
<li>Hypersensitivity to iobitridol or any of the excipients.</li>
<li>History of a major immediate reaction or delayed skin reaction (see sections 4.4 and 4.8 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>) to a Xenetix® injection.</li>
<li>Manifest thyrotoxicosis</li>
<li>In the absence of specific studies, myelography is not an indication for Xenetix®.</li>
<li>Hysterosalpingography during pregnancy is contraindicated for Xenetix® 300.</li>
</ul>
- Atc Code
- V08AB11
- Atc Item Name
- iobitridol
- Pharma Manufacturer Name
- TRANSMEDIC PTE LTD
